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Streamlining Submissions with Product Adoption for Radiation Sterilization

Streamlining Submissions with Product Adoption for Radiation Sterilization

Product adoption for radiation sterilization can cut costs and save time today and in the future.


In an industry that is fast-paced and high-stakes, identifying areas to streamline a project is key to a manufacturer’s success. For some, product adoption for radiation sterilization is an option that can save time and money. By adopting a product into an existing product family, you can avoid the lengthy dose establishment process and the costs associated with it. The right partner can make the process easier and help you receive approval from regulatory bodies faster.


Before kicking off this project with your testing partner, there are preliminary steps you need to take to begin the product adoption process. First, determine which existing family the candidate product is going to fit into, then complete a technical review. For a successful technical review, it’s vital to have intimate product knowledge on materials, design and the manufacturing process. Additionally, a capable and experienced team that is equipped with critical product knowledge can streamline the process and help avoid documentation mistakes.


After completing the technical review, there are three methods to achieve adoption:


  1. Documentation Adoption:

    This method of adoption is based on the results of the technical review and can be utilized if the candidate product is deemed equivalent to or a lesser challenge to the sterilization process than the family representative.

  2. Bioburden Adoption:

    If the technical review reveals variables that need further consideration, a bioburden evaluation can provide further insight. This evaluation compares the variables at hand that affect bioburden against the data from the product family’s validation. Your testing partner will assist with this process.

  3. Dose Audit Adoption:

    When the bioburden data is inconclusive or there are significant differences found in the bioburden compared to that of the family representative, a dose audit adoption is performed. A dose audit adoption entails subjecting the candidate product to the verification dose established for the family, then a test of sterility is completed by your testing partner. If the results prove that the differences are minor enough for product adoption, the candidate product can be adopted. If not, an independent dose establishment will need to be performed for the candidate product.


To ensure you are going down the right path with product adoption for radiation sterilization, testing facilities, like WuXi AppTec, can help you identify and navigate the best method for your product. Additionally, there are resources available to guide this process, such as the AAMI TR35:2016, which outlines the process in a flowchart.


One step in the product adoption process that is often overlooked is actually one of the easiest. Be sure to document the process and rationalize the “why” of each step. While having legacy knowledge in your company is extremely valuable, documenting the reason behind testing decisions or the connection between a candidate product and the adoptive family can provide important answers down the road, should your team change. Another advantage of thorough documentation is that you and your team can rest easy knowing you are prepared, should the company be audited or reviewed.


While a testing partner only provides testing support if you are completing bioburden or dose audit adoption, they can still help you with documentation, such as developing a formal report of the adoption steps and more. Additionally, your testing partner will typically provide a standardized report, which is required for all adoption processes when reporting to the FDA. This thorough documentation can help you avoid requests for additional information from regulatory bodies.


The time and cost-savings of a product adoption continue through the product’s lifecycle. When adopting a product into an existing family, it does not need to undergo a full validation process. The standardized report from your testing partner will include the set sterilization dose for the product family. Additionally, only the representative product of the family is required for a dose maintenance audit when necessary.


Product adoption can save your company significant resources. Still, it is critical to follow the process carefully to avoid additional requests from regulatory bodies or complications with audits in the future. Having a good partnership is essential to the success of your product adoption, and WuXi AppTec is committed to offering support every step of the way. To learn more about the radiation sterilization product adoption, visit WuXi AppTec Medical Device Testing’s website. 


WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated.”


For more information, please visit: https://medicaldevice.wuxiapptec.com